§ 862.1377. Urinary homocystine (nonquantitative) test system.
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/us/cfr/t21/s§ 862.1377·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.
(b)Classification. Class II.